important. In case the indications for use are different, that machine gained’t be an appropriate predicate. The technological characteristics ought to closely match your unit.
The FDA's purpose to safeguard community wellbeing by making certain the protection and success of healthcare gear highlights the importance of a thorough 510(k) submission.
Your system was legally in industrial distribution prior to May 28, 1976 and it has not been appreciably modified or modified in design and style, elements, means of manufacture, or intended use. These devices are "grandfathered" and you have Preamendment Status documentation to prove this.
This program is aimed toward experts who perform in regulatory affairs and are involved with the approval of therapeutics during the US. These incorporate:
Share Write-up Linkedin E-mail Print This record involves cleared 510(k) submissions for 2024 for which We now have supporting documents offered, and demonstrates the data as on the clearance date. It's not at all up to date regarding applicant or software standing modify.
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Examples FDA 510k are transvaginal mesh implants which didn't require substantial screening before they were accepted given that they ended up modeled immediately after Boston Scientific’s ProtoGen sling.
Atlas Spine CEO and CTO Matt Baynham commented, “Atlas is on an aggressive growth pathway toward broadening its expandable technologies platform, and this addition is an important stage forward for our progress.”
Some companies creating innovative very low-chance clinical units without having a suitable predicate product can go through the De Novo
Obtaining FDA clearance for your medical system is loads of function and a large accomplishment. Should you shell out time doing your homework, it is possible to be confident that your path to 510(k) accomplishment are going to be shorter, smoother, plus much more very likely to lead to you securing the coveted considerably equal letter.
In addition, the FDA is dedicated to safeguarding community wellness by guaranteeing the safety and performance of healthcare devices. It is important to follow FDA tips when submitting any reviews or documentation, making certain that no private details is inadvertently made community.
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This ensures that any differing technological characteristics tend not to pose new concerns of basic safety and usefulness.